The Division of Pulmonary and Critical Care Medicine is seeking someone experienced in clinical research to support an NIH funded multi-site projects The investigator works primarily within cystic fibrosis and bronchiectasis therapeutic areas so experience with pulmonary diseases and testing will be very helpful. This position will work closely with the Program Director to launch an NIH funded multi-site trial, where Michigan Medicine is the data coordinating and clinical coordinating center, by developing essential study documents, manuals, procedures, and onboarding sites by facilitating contracting, training etc. The study evaluates outcomes for patients randomized to two different standard-of-care treatments. Once the project is launched this position will be the primary point of contact for issues related to study operations and coordinate/manage bi-annual DSMB meetings. Other duties will include working with the Program Director to identify funding opportunities and develop grant applications accordingly, providing necessary reporting to various funders, assisting with development of manuscripts, abstracts, posters etc., and collaborating in the planning and execution of strategic initiatives of the program.
This is a foundational position with a program poised for growth. As such, there will be significant opportunities to develop new skills, take on new responsibilities and projects, and grow professionally with the support and mentorship of the Program Director. It will be an excellent opportunity for an experienced individual who is a self-starter and wishes to grow in their career and be a partner in the growth of the program.
Lead all aspects of an NIH sponsored multi-site investigator initiated trial encompassing 10-15 sites
- Develop all necessary essential study documents, tools, manuals, processes etc.
- Build RedCap registry and any necessary guidance documents to facilitate accurate and high quality data collection
- Facilitate DSMB review for the project and participating sites
- Serve as primary point of contact for study-related issues and needs
- Onboard participating sites by facilitating contract execution and registry access
- Train participating sites in study related procedures and data collection
- Manage data quality for participating sites
- Liaise with biostats support regarding aims of project and analysis
- Conduct project meetings that include participating sites
Regulatory Support:
- Complete new study applications, continuing reviews, event reporting as needed in support of the program portfolio
- Liaise with study sponsors to provide necessary regulatory documents for study start-up and close-out
- Work with central IRBs as needed to facilitate study approvals
Support program growth and visibility:
- Provide input on grant proposals and applications;
- Assist with identifying funding opportunities and/or relevant clinical trials to ensure a well-rounded portfolio
- Assist with the development of manuscripts, posters, abstracts by writing specific portions, performing literature reviews etc.
- Attend network, society and other national meetings representing the program
- Present posters, abstracts etc. as needed
Administrative duties:
- Assisting with planning/scheduling program meetings as needed
- Sit in on financial meetings and work to conceptually understand impact of financial decisions
- Complete all necessary training required by institution, networks, sponsors etc.
- Work with Program Director to develop plans and strategies to facilitate growth of the program?s portfolio, assist with execution of strategic initiatives
- Other duties as assigned and/or agreed upon with Program Director
Masters degree or an equivalent combination of education and experience is necessary.
Minimum of 5 years of clinical research experience
Experience authoring and/or editing portions of manuscripts, posters, abstracts
Prior experience with eResearch and preparation of new study applications, event reporting, continuing reviews, etc.
Experience working in Oncore and MiCHART
Demonstrated understanding of study/grant financials to the extent that candidate can ensure good stewardship of study/grant funds
Prior experience providing mentorship and/or functional oversight
Willingness to travel to national meetings and conferences as needed; approx. 1-3 times per year
Experience assisting with the development of grant proposals/applications and funder reporting
Experience with pulmonary disease populations
Experience with NIH funded trials
Experience with multi-center investigator initiated trials
Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (
